The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer

This study has been terminated.
(Budgetary)
Sponsor:
Information provided by (Responsible Party):
Synovis Surgical Innovations
ClinicalTrials.gov Identifier:
NCT00958711
First received: August 11, 2009
Last updated: May 15, 2012
Last verified: September 2011
  Purpose

The purpose of this study is to assess the mechanism of action of the Unite Biomatrix and compare its performance with the standard of care, saline moistened gauze, for the treatment of diabetic foot ulcers.


Condition Intervention
Diabetic Foot Ulcers
Device: Unite Biomatrix
Other: Saline and Gauze

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer

Resource links provided by NLM:


Further study details as provided by Synovis Surgical Innovations:

Primary Outcome Measures:
  • time to complete healing [ Time Frame: Day -7 (baseline), day 0, 72 hours, wk 1, wk 2, wk 4 ] [ Designated as safety issue: No ]
  • percent of wounds healed at 12 weeks [ Time Frame: Day 0, wks 1 - 12 ] [ Designated as safety issue: No ]
  • wound healing pathway markers [ Time Frame: day 0, 72 hours, wk 1, wk 2, wk 4 ] [ Designated as safety issue: No ]
  • bacterial burden [ Time Frame: day 0, wk 1 - 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1) mean & median of % wound size changes 2) ulcer recurrence 3) adverse events [ Time Frame: wk 4, wk 8, wk 12 ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: January 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biologic - Unite Biomatrix Device: Unite Biomatrix
Collagen based, decellularized equine pericardial dressing for skin surface wounds
Active Comparator: Saline and Gauze Other: Saline and Gauze
gauze moistened with sterile saline

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A full thickness diabetic foot ulcer with a viable wound bed free of necrotic material (grade 1 on Wagner scale).
  2. Diagnosis of diabetes mellitus (type I or II) adequately controlled.
  3. The ulcer is greater than 4 weeks duration.
  4. Three or fewer ulcers separated by > 3.0 cm distance.
  5. Post-debridement, the ulcer size must be between 1 and 10 sq cm2.
  6. Ankle/brachial index is between 0.7 to 1.2 and or one of the following must be present:

    • transcutaneous partial pressure oxygen (TcPO2) > 30 mmHg at the ankle
    • toe pressure of >40mm Hg or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic)
  7. At least 18 years old.
  8. Able and willing to provide a voluntary written informed consent.
  9. Able and willing to wear an off-loading orthopedic shoe.
  10. Able and willing to attend scheduled follow-up visits and study related exams.

Exclusion Criteria:

  1. Greater than 30% reduction in wound size during first week of observation by the investigator.
  2. Ulcer with exposed tendon or bone.
  3. Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis.
  4. Gangrene.
  5. Active Charcot's disease as determined by clinical and radiographic examination.
  6. Ulcer of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers).
  7. Known severe anemia.
  8. Known serum albumin < 2.5.
  9. Renal failure with Creatinine > 2.5.
  10. Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV.
  11. Severe liver disease as defined by the treating physician or patient's primary care physician.
  12. Malignancy at or near the ulcer site.
  13. Any condition judged by the investigator that would cause the study to be detrimental to the patient.
  14. Presence of a hematology, clinical, chemistry or other test obtained within 7 days of screening that is outside the normal range for the laboratory and is determined to be clinically significant by the investigator.
  15. Received another investigational device or drug within 30 days of Day 0.
  16. Radiation therapy, chemotherapy or immunosuppressive therapy within 30 days of enrollment.
  17. Received another allograft, autograft or xenograft within 30 days of the Day 0.
  18. Known allergy to equine derived tissue.
  19. Alcohol or drug abuse, defined as current medical treatment for substance abuse.
  20. Pregnant or nursing women.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958711

Locations
United States, California
University of California - San Diego
San Diego, California, United States, 92103
United States, Florida
University of Miami, Miller School of Medicine
Miami, Florida, United States, 33136
United States, Georgia
Aiyan Diabetes Center
Evans, Georgia, United States, 30809
United States, Illinois
Foot & Ankle Associates of Central Illinois, LLC
Springfield, Illinois, United States, 62704
United States, North Carolina
Eastern Carolina Foot and Ankle
Greenville, North Carolina, United States, 27834
Family Foot & Ankle Physicians
Greenville, North Carolina, United States, 27858
Carolina East Family Medicine
Greenville, North Carolina, United States, 27858
Foot and Ankle East
Greenville, North Carolina, United States, 27834
Comprehensive Wound Care Thoracic & Vascular Associates of Kinston P.A.
Kinston, North Carolina, United States, 28504
The Foot & Ankle Associates of North Carolina, PLLC
Rocky Mount, North Carolina, United States, 27804
United States, Pennsylvania
Martin Foot and Ankle
York, Pennsylvania, United States, 17403
Sponsors and Collaborators
Synovis Surgical Innovations
  More Information

No publications provided

Responsible Party: Synovis Surgical Innovations
ClinicalTrials.gov Identifier: NCT00958711     History of Changes
Other Study ID Numbers: U-0801
Study First Received: August 11, 2009
Last Updated: May 15, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on August 20, 2014